心臟 POC 测试设备市场 - 增长、趋势、COVID-19 影响和预测（2022-2027 年）

在预测期间（2022-2027 年），心臟 POC 测试设备市场预计将以 6.5% 的复合年增长率增长。

COVID-19 大流行对心臟 POC 测试设备的製造和分销产生了重大影响。此外，由于与 COVID-19 相关的措施导致心血管疾病检测的缩减对心臟 POC 检测设备市场产生了负面影响，尤其是在 2020 年。由于为 COVID-19 患者保留的医疗资源导致心血管疾病诊断延迟也是对市场产生负面影响的因素之一。然而，政府封锁、供应链中断和贸易禁令也在影响心臟 POC 测试设备市场。

根据 Tarun Dalia 等人于 2021 年 2 月在《印度心臟杂誌》上发表的一篇研究论文，COVID 患者发生充血性心力衰竭 (CHF) 与死亡率增加和预后更差有关。非倖存者和重症 COVID-19 患者发生急性心肌损伤和心力衰竭的风险也增加。像这样的研究表明了诊断冠状病毒感染患者心臟病的重要性。因此，人们对快速检测和早期诊断心脏病的需求日益增长，预计将在预测期内为目标市场创造有利可图的机会。

此外，心血管疾病患病率的增加、技术的进步、门诊检测服务利用率的提高、优惠的报销政策等是推动心臟POC检测设备市场增长的主要因素。我来了。例如，根据世界卫生组织 (WHO) 2021 年 6 月更新的数据，全球约有 3350 万人患有心房颤动 (AFib)，这是最常见的严重心律失常类型。此外，美国心臟协会 2020 年心臟和中风统计更新发现，美国每年发生超过 356,000 例院外心臟骤停 (OHCA)，其中 90.0% 以上是致命的。非创伤性 OHCA 的年发病率为 356,461 例，估计每天发生 1,000 例。因此，对早期发现心脏病和感染的快速 POC 测试的需求正在增加，这有望在研究期间促进市场的增长。此外，随着全球人口老龄化，预计患有心脏病的患者人数将增加，预计在预测期内对心脏病 POC 检测设备的需求将增加。

对研发活动的投资不断增加，以及因心脏病负担增加而导致的即时检测需求增加，预计将推动目标市场的增长。例如，根据美国卫生与公众服务部 2021 年 11 月的一份报告，拜登政府已宣布将投资约 6.5 亿美元用于快速诊断测试和提高国内诊断製造能力。预计这将增加对快速和即时检测的需求，这将对研究目标市场的增长产生重大影响。

此外，市场参与者不断推出的产品预计将进一步推动该市场的增长。例如，2021 年 7 月，Beckman Coulter Inc. 与 Quidel Corporation 签订了最终协议，以获取製造、分销和销售用于 Beckman Coulter 分析仪的 BNP 测试的所有权利。根据协议条款，Quidel 将继续为 Beckman Coulter 製造和供应某些与测试相关的组件，而 BNP 测试将由 Beckman Coulter 独家製造。同样，在 2020 年 7 月，Sphingotech 推出了 CE-IVD 标记的即时检验“IB10 Sphingotest Bio-ADM”，定量测量了生物活性肾上腺髓质素 (bio-ADM) 的血液浓度。预计这将增加向患者引入心臟 POC 设备，并成为市场增长的驱动力。

但是，预计工人缺乏操作知识和严格的法规会抑制市场增长。

主要市场趋势

分析器部分预计将在预测期内增长

该分析仪提供高分辨率即时诊断，用于检测心肌梗塞和心房颤动等心脏病。这些设备监测心臟分泌的□和蛋白质的数量。此外，量化全血、血清和血浆中生物标誌物浓度的能力是推动分析仪行业增长的关键因素，因为它在临床诊断中的有用性。使用该分析仪，可以测试各种类型的生物标誌物，例如心肌标誌物肌钙蛋白 I、NT-proBNP、h-FABP、CK-MB 和肌红蛋白。

此外，这一细分市场的增长还得益于领先公司推出的能够一次性提供高灵敏度、快速和准确结果的创新产品，以及有助于临床诊断的产品的增加。例如，2021 年 4 月，Siemens-Herchiners 获得了 Atellica VTLi 患者侧免疫分析分析仪的 CE 标誌。 Atellica VTLi 分析仪使用患者的指尖血样在 8 分钟内为临床医生提供实验室标准、高灵敏度的心肌肌钙蛋白 I (hs-cTnI) 结果。

因此，由于上述因素，预计该行业在预测期内将出现可观的增长。

预计北美将主导心臟 POC 测试设备市场

由于该国心血管疾病发病率增加等因素，预计北美将在心臟 POC 测试设备市场占据最大的市场份额。此外，人口增长、人口老龄化、遗传易感性和行为风险因素导致热相关疾病的发病率上升。缺乏运动、不健康的生活方式、不良的饮食习惯、慢性压力、吸烟和过度饮酒。这些风险因素可能以高血压、高血糖、血脂水平以及超重和肥胖的形式产生长期影响。中风和心臟骤停是这些风险因素可能导致的两种典型结果。与 CVD 发病相关的经济负担也是日本非常关注的问题。根据美国心臟协会 2021 年 1 月更新的数据，到 2035 年，45.0% 的美国人口可能会因高度肥胖、过度吸烟和不健康的生活方式而患有心脏病。

一些公司将推出各种策略，例如合作伙伴关係、新产品发布和併购，以保持其市场份额。例如，2021 年 4 月，罗氏宣布了基于 Elecsys 技术的高灵敏度心肌肌钙蛋白 T (cTnT-hs) 和 N 端脑利钠□前体检测这两种关键心臟生物标誌物的五项新用途。 (NT-proBNP)。这些临床生物标誌物有助于诊断心肌梗塞并有效控制心力衰竭。

因此，由于上述市场发展，预计北美市场在预测期内将增长。

其他特典

• Excel 格式的市场预测 (ME) 表
• 3 个月的分析师支持

内容

第 1 章介绍

• 研究假设和市场定义
• 调查范围

第 2 章研究方法

第 3 章执行摘要

第 4 章市场动态

• 市场概览
• 市场促进因素
  • 心血管疾病的发病率和患病率不断上升
  • 心臟POC检测设备的技术进步
• 市场抑制因素
  • 工人缺乏操作知识
  • 行业内的严格规定
• 波特五力分析
  • 新进入者的威胁
  • 买方/消费者议价能力
  • 供应商的议价能力
  • 替代品的威胁
  • 竞争公司之间的敌对关係

第 5 章市场细分（基于价值的市场规模:百万美元）

• 按产品类型
  • 心臟标誌物测试
    • 心肌肌钙蛋白 (cTn) 测试
    • 肌红蛋白测试
    • 肌酸激□ MB 同工□ (CK-MB) 测试
    • 复合检测试剂盒
    • 用于测量脑利钠□ (BNP)
  • 分析器
• 按最终用户
  • 医院
  • 诊断机构
  • 其他最终用户
• 按地区
  • 北美
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 其他欧洲地区
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 澳大利亚
    • 韩国
    • 其他亚太地区
  • 中东和非洲
    • 海合会
    • 南非
    • 其他中东和非洲
  • 南美洲地区
    • 巴西
    • 阿根廷
    • 其他南美洲

第 6 章竞争格局

• 公司简介
  • Abbott Laboratories
  • ACON Laboratories, Inc.
  • Alfa Scientific Designs, Inc.
  • American Screening Corporation, Inc.
  • Beckman Coulter Inc.（Danaher Corporation）
  • Biomerica, Inc.
  • Bio-Rad Laboratories, Inc.
  • F. Hoffmann-La Roche AG
  • LifeSign LLC
  • Nano-Ditech Corporation
  • Nexus Dx, Inc.
  • Nova Biomedical Corporation
  • PTS Diagnostics
  • Sekisui Medical Co., Ltd.
  • Siemens Healthineers AG

第 7 章市场机会和未来趋势

Cardiac PoC Testing Devices Market is expected to grow at a CAGR of 6.5% over the forecast period (2022-2027).

The COVID-19 pandemic has significantly impacted the manufacturing and distribution of cardiac POC testing devices. In addition, the reduction in cardiovascular disease testing due to the measures related to COVID-19 has adversely affected the cardiac POC testing devices market, especially in 2020. Another factor that is negatively impacting the market is the delay in the diagnosis of cardiovascular diseases due to healthcare resources. reserved for patients with COVID-19. However, government-mandated lockdowns, supply chain disruptions, and trade bans have also affected the cardiac POC testing devices market.

According to a research article by Tarun Dalia et al., published in the Indian Heart Journal in February 2021, the occurrence of congestive heart failure (CHF) in patients with COVID is associated with increased mortality and worse outcomes. In addition, there is an increased risk of acute heart damage and cardiac arrhythmia in non-survivors and patients with severe COVID-19 disease. Such studies show the importance of diagnosing heart disease in patients infected with the coronavirus. Therefore, the growing need for rapid tests and early diagnosis of heart diseases among people is expected to create lucrative opportunities for the target market during the forecast period.

In addition, the increasing prevalence of cardiovascular disorders, technological advancements, increase in the use of ambulatory services for testing, and favorable reimbursement policies are key factors driving the growth of the cardiac POC testing devices market. For example, according to World Health Organization (WHO) data updated in June 2021, nearly 33.5 million people worldwide suffer from atrial fibrillation (AFib), the most common type of serious arrhythmia. Additionally, according to the American Heart Association's 2020 Heart and Stroke Statistics Update, more than 356,000 out-of-hospital cardiac arrests (OHCAs) occur in the United States each year, and more than 90.0% of them are fatal. The annual incidence of non-traumatic OHCA is estimated to be 356,461, or about 1,000 people every day. This will lead to an increased need for rapid POC tests for early detection of cardiac diseases or infections and is therefore expected to boost the growth of this market over the study period. Moreover, with the increase in the aging population worldwide, the number of patients suffering from cardiac disorders is likely to increase and the demand for cardiac POC testing devices is anticipated to rise over the forecast period.

The rising demand for point-of-care testing due to the increasing burden of heart diseases along with rising investment in research and development activities is likely to fuel the growth of the target market. For example, according to a November 2021 report from the United States Department of Health and Human Services, the Biden administration announced that it would invest approximately USD 650.0 million in rapid diagnostic testing and strengthening domestic diagnostic manufacturing capacity. This is expected to have a significant impact on the growth of the studied market as the demand for rapid testing and point-of-care testing increases.

Moreover, Moreover, rising product launches by the market players are expected to drive this market's growth further. For instance, in July 2021, Beckman Coulter Inc. entered into definitive agreements with Quidel Corporation to acquire all rights related to the manufacture, distribution and sale of the BNP test for Beckman Coulter analyzers. Under the terms of the agreement, Quidel will continue to manufacture and supply certain test-related components to Beckman Coulter, and Beckman Coulter will exclusively manufacture the BNP test. Similarly, in July 2020, SphingoTec GmbH launched IB10 sphingotest bio-ADM, a CE-IVD-marked point-of-care test to quantitatively determine blood levels of Bioactive Adrenomedullin (bio-ADM). This will lead to increased adoption of cardiac PoC devices in patients, driving the market growth.

However, a lack of operating knowledge among the workforce and stringent regulations are expected to restrain the market growth.

Key Market Trends

Analyzer Segment is Expected to Witness Growth Over the Forecast Period

The analyzers offer high-resolution point-of-care diagnostics for the detection of heart diseases such as myocardial infarction, atrial fibrillation, and more. These devices monitor the number of enzymes and proteins secreted by the heart. Moreover, it is a key factor driving the growth of the analyzer segment such as its ability to quantify the concentration of biomarkers in whole blood, serum, and plasma, which helps in clinical diagnosis. Different types of biomarkers can be tested using the analyzers including cardiac markers Troponin I, NT-proBNP, h-FABP, CK-MB, Myoglobin, and others.

In addition, the growth of the segment is driven by the launch of innovative products from major companies that can offer highly sensitive, rapid, and accurate results in one-step and ancillary clinical diagnosis. For example, in April 2021, Siemens Healthineers received the CE mark for the Atellica VTLi Patient-Side Immunoassay Analyzer. The Atellica VTLi analyzer provides laboratory-standard high-sensitivity cardiac troponin I (hs-cTnI) results to clinicians in eight minutes using a patient fingertip blood sample.

Therefore, the above-mentioned factors indicate that the segment is anticipated to witness considerable growth over the forecast period.

North America is Expected to Dominate the Cardiac POC Testing Devices Market

North America is expected to hold the largest market share in the cardiac POC testing devices market due to factors such as the increasing incidence of cardiovascular diseases in the country. Additionally, increased population, aging demographics, genetic predisposition, and behavioral risk factors are contributing to the increased incidence of heat-related illnesses. Lack of physical exercise, unhealthy lifestyle, poor eating habits, chronic stress, smoking, and excessive alcohol consumption. Such risk factors can have long-term consequences in the form of high blood pressure, high blood glucose, and lipid levels, as well as overweight and obesity. Stroke and cardiac arrest are two typical consequences that can occur as a result of these risk factors. The economic burden associated with the incidence of CVD is a major source of concern in the country. According to data from the American Heart Association updated in January 2021, by 2035, 45.0% of the United States population will likely suffer from heart disease due to high levels of obesity, excessive smoking, and unhealthy lifestyles.

Several companies initiate various strategies such as collaborations, new product launches, and mergers and acquisitions to maintain their market shares. For example, in April 2021, Roche announced five new intended uses for two critical cardiac biomarkers, the high-sensitivity cardiac troponin T (cTnT-hs) and the N-terminal pro-brain natriuretic peptide assay, both based on Elecsys technology. (NT-proBNP). These clinical biomarkers help diagnose heart attacks and effectively manage heart failure.

Thus, due to the above-mentioned developments, the market in North America is expected to grow during the forecast period.

Competitive Landscape

The cardiac POC testing devices market is competitive in nature due to the presence of several companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies which hold the market shares and are well known including Abbott Laboratories, ACON Laboratories, Inc., Alfa Scientific Designs, Inc., American Screening Corporation, Inc., Beckman Coulter Inc. (Danaher Corporation), Biomerica, Inc., Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche AG, LifeSign LLC, Nano-Ditech Corporation, Nexus Dx, Inc., Nova Biomedical Corporation, PTS Diagnostics, Sekisui Medical Co., Ltd., and Siemens Healthineers AG among others.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Incidence and Prevalence of Cardiovascular Disease
  • 4.2.2 Technological Advances in Cardiac POC Testing Device
• 4.3 Market Restraints
  • 4.3.1 Lack of Operating Knowledge among Workforce
  • 4.3.2 Stringent Regulations in the Industry
• 4.4 Porter's Five Force Analysis
  • 4.4.1 Threat of New Entrants
  • 4.4.2 Bargaining Power of Buyers/Consumers
  • 4.4.3 Bargaining Power of Suppliers
  • 4.4.4 Threat of Substitute Products
  • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD million)

• 5.1 By Product Type
  • 5.1.1 Cardiac Markers Test
    • 5.1.1.1 Cardiac Troponin (cTn) Test
    • 5.1.1.2 Myoglobin Test
    • 5.1.1.3 Creatine Kinase MB Isoenzyme (CK-MB) Test
    • 5.1.1.4 Combinational Test Kits
    • 5.1.1.5 Brain Natriuretic Peptide (BNP) Test
  • 5.1.2 Analyzers
• 5.2 By End User
  • 5.2.1 Hospitals
  • 5.2.2 Diagnostic Laboratories
  • 5.2.3 Other End Users
• 5.3 Geography
  • 5.3.1 North America
    • 5.3.1.1 United States
    • 5.3.1.2 Canada
    • 5.3.1.3 Mexico
  • 5.3.2 Europe
    • 5.3.2.1 Germany
    • 5.3.2.2 United Kingdom
    • 5.3.2.3 France
    • 5.3.2.4 Italy
    • 5.3.2.5 Spain
    • 5.3.2.6 Rest of Europe
  • 5.3.3 Asia-Pacific
    • 5.3.3.1 China
    • 5.3.3.2 Japan
    • 5.3.3.3 India
    • 5.3.3.4 Australia
    • 5.3.3.5 South Korea
    • 5.3.3.6 Rest of Asia-Pacific
  • 5.3.4 Middle-East and Africa
    • 5.3.4.1 GCC
    • 5.3.4.2 South Africa
    • 5.3.4.3 Rest of Middle-East and Africa
  • 5.3.5 South America
    • 5.3.5.1 Brazil
    • 5.3.5.2 Argentina
    • 5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Abbott Laboratories
  • 6.1.2 ACON Laboratories, Inc.
  • 6.1.3 Alfa Scientific Designs, Inc.
  • 6.1.4 American Screening Corporation, Inc.
  • 6.1.5 Beckman Coulter Inc. (Danaher Corporation)
  • 6.1.6 Biomerica, Inc.
  • 6.1.7 Bio-Rad Laboratories, Inc.
  • 6.1.8 F. Hoffmann-La Roche AG
  • 6.1.9 LifeSign LLC
  • 6.1.10 Nano-Ditech Corporation
  • 6.1.11 Nexus Dx, Inc.
  • 6.1.12 Nova Biomedical Corporation
  • 6.1.13 PTS Diagnostics
  • 6.1.14 Sekisui Medical Co., Ltd.
  • 6.1.15 Siemens Healthineers AG

7 MARKET OPPORTUNITIES AND FUTURE TRENDS